NCT06261242

Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment

A Study of Tripod-Fix Vertebral Body Augmentation System in Vertebral Compression Fractures Caused by Osteoporosis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and effectiveness of the Tripod-Fix with Tecres Mendec® Spine HV System to treat subjects with osteoporotic vertebral compression fractures.

Detailed description

This study is a prospective, single-center, open-label, single-arm study. This study will screen up to 12 eligible patients. Eligible patients will be treated with Tripod-Fix on the Day 1 and follow-up for 12 months. Patients will be asked to return to the study site for assessments on the Day 5, 1st month, 6th month and 12th month. Safety will be assessed by the investigator(s) at each return visit and will be monitored until the end of the study.

Conditions

• Osteoporotic Vertebral Compression Fractures

Interventions

Type	Name	Description
DEVICE	Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix)	The Tripod-Fix is a permanent implant used for vertebral augmentation in patients with osteoporotic vertebral compression fractures.

Timeline

• Start date: 2023-06-16
• Primary completion: 2026-01-31
• Completion: 2026-09-30
• First posted: 2024-02-15
• Last updated: 2025-07-09

Locations

1 site across 1 country: Taiwan